Identity
- Trade Name
- DR,EYE,SMS,130X140,1P EUDAMED
- Device Name
- Medical Drapes, Medical Gowns and Medical Equipment Covers, Sterile EUDAMED
- Model / Reference
- 108255AA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08710685033614 EUDAMED
- Basic UDI-DI
- 8710685TF05001001QV EUDAMED
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dr, Eye, Sms, 130x140, 1p by Medica Europe B.V. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8710685TF05001001QV | Class I | Active |
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Manufacturer
- Manufacturer
- Medica Europe B.V.
- EUDAMED SRN
- NL-MF-000000118
Sources (1)
- EUDAMED 44618703-e040-47b1-b495-cca33e6dadca 61 fields · synced Oct 6, 2026